Vectibix Concentrate for Solution for Infusion 100 mg/vial

INFUSION, SOLUTION CONCENTRATE

**Posology and method of administration** Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Evidence of wild-type _RAS_ ( _KRAS_ and _NRAS_) status is required before initiating treatment with Vectibix. Mutational status should be determined by an experienced laboratory using validated test methods for detection of _KRAS_ (exons 2, 3 and 4) and _NRAS_ (exons 2, 3 and 4) mutations. Posology The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks. Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:  _Special populations_ The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment. There is no clinical data to support dose adjustments in the elderly. _Paediatric population_ There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer. Method of administration Vectibix must be administered as an intravenous infusion via an infusion pump. Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration not to exceed 10 mg/mL (for preparation instructions see Special precautions for disposal and other handling section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes. Doses higher than 1,000 mg should be infused over approximately 90 minutes (for handling instructions, see Special precautions for disposal and other handling section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions. A reduction in the rate of infusion of Vectibix may be necessary in cases of infusion-related reactions (see Special warnings and precautions for use section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Vectibix must not be administered as an intravenous push or bolus. For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.